Cleaning separation method

Abstract

The application relates to a cleaning and separating method. The method comprises the following steps: moving an empty reactor to a pipetting station, injecting a reaction solution into the reactor through a sampling mechanism; moving the reactor after the reaction solution is injected out of a magnetic collection assembly; mixing the liquid in the reactor; moving the mixed reactor into an incubation mechanism for incubation; moving the reactor after the incubation is completed into the magnetic collection assembly and moving to the pipetting station, collecting magnetic beads in the reactor on the inner wall of the reactor, and sucking waste liquid through the sampling mechanism; moving the reactor after the waste liquid is sucked to a liquid injection station, injecting a cleaning solution into the reactor through a first liquid injection assembly; moving the reactor after the cleaning solution is injected out of the magnetic collection assembly; mixing the liquid in the reactor; moving the reactor containing the cleaning solution to the pipetting station to collect the magnetic beads in the reactor on the inner wall of the reactor, and sucking waste liquid through the sampling mechanism. In this way, the manufacturing cost and volume of the cleaning and separating device are reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a cleaning and separation method. Background Technology

[0002] Immunoassay technology has gained increasingly widespread application in recent years due to its advantages such as high sensitivity, good specificity, wide linear range, high throughput, strong platform scalability, and rich menu of measurable items. The cleaning device is the core component of immunoassay technology, and the cleaning separation method is used to clean the bound substances to magnetic beads. However, while traditional cleaning separation methods offer high throughput, the cleaning devices used to perform these methods are expensive, bulky, and require highly specialized operation, making them unsuitable for small and medium-sized laboratories or medical institutions, thus limiting the availability of immunoassay technology. Summary of the Invention

[0003] One technical problem addressed by this application is how to reduce the manufacturing cost and size of the cleaning and separation apparatus for performing the cleaning and separation method.

[0004] A cleaning and separation method involves a reactor supported by a magnetic collection assembly moving linearly between spaced-apart pipetting and injection stations. The cleaning and separation method includes the following steps:

[0005] The empty reactor is moved to the liquid transfer station, and the reaction liquid is injected into the reactor through the sampling mechanism; the reactor after the reaction liquid is injected is moved out of the magnetic collection assembly;

[0006] Mix the liquid in the reactor thoroughly;

[0007] The well-mixed reactor is then transferred to an incubation apparatus for incubation.

[0008] After incubation, the reactor is moved into the magnetic collection assembly and then to the liquid transfer station. The magnetic beads in the reactor are collected on the inner wall of the reactor, and the waste liquid is extracted through the sampling mechanism.

[0009] After the waste liquid is absorbed, the reactor is moved to the liquid injection station, and cleaning liquid is injected into the reactor through the first liquid injection component;

[0010] Remove the reactor from the magnetic collection assembly after the cleaning fluid has been injected;

[0011] The liquid in the reactor is mixed; the reactor containing the cleaning solution is moved to the transfer station to collect the magnetic beads in the reactor on the inner wall of the reactor, and the waste liquid is removed through the sampling mechanism.

[0012] In one embodiment, the magnetic collection assembly carrying the reactor passes through a transfer station spaced apart from the pipetting station and the injection station, and the magnetic collection assembly moves linearly between the pipetting station, the injection station and the transfer station, moving the reactor into or out of the magnetic collection assembly at the transfer station.

[0013] In one embodiment, the injection station is located between the pipetting station and the transfer station.

[0014] In one embodiment, after the reactor has drawn off waste liquid for the last time, the substrate liquid is injected into the reactor at the injection station via a second injection assembly.

[0015] In one embodiment, the number of injection stations is two, referred to as the first injection station and the second injection station, respectively. A cleaning solution is injected into the reactor at the first injection station, and a substrate solution is injected into the reactor at the second injection station.

[0016] In one embodiment, the magnetic collection assembly has a sample loading position and a collection position for carrying the reactor, the sample loading position and the collection position being spaced apart along the movement direction of the magnetic collection assembly, the sample loading position being movable to the pipetting station, and the collection position being movable to the pipetting station or the injection station.

[0017] In one embodiment, there are multiple collection locations. For two adjacent collection locations, the reactor injects cleaning liquid into one collection location and then moves to the other collection location to collect waste liquid.

[0018] In one embodiment, the reactor containing the reaction liquid is moved to the injection station to inject cleaning liquid before the waste liquid is drawn from the reactor.

[0019] In one embodiment, the step from the injection of cleaning liquid to the removal of waste liquid from the reactor after the reaction liquid has been completely absorbed is referred to as a first-stage cleaning and separation process, and the cleaning and separation method includes multiple stages of the cleaning and separation process.

[0020] In one embodiment, at least one of the following steps is also included:

[0021] The liquid in the reactor is mixed using the same mixing mechanism;

[0022] After the sampling mechanism injects the reaction liquid or removes the waste liquid, the sampling component of the sampling mechanism is cleaned.

[0023] One technical advantage of one embodiment of this application is that, by making the magnetic collection component move linearly between the injection station and the transfer station, the volume of the magnetic collection component is reduced and the manufacturing cost is lowered, thereby achieving a miniaturized design of the cleaning and separation device for performing the cleaning and separation method and reducing the manufacturing cost of the cleaning and separation device. Furthermore, the same sampling element is used for both the injection of the reaction liquid and the aspiration of the waste liquid, thus reducing the number of sampling elements and the number of drive sources for moving the sampling elements, thereby further reducing the manufacturing cost and volume of the cleaning and separation device. Attached Figure Description

[0024] Figure 1 This is a three-dimensional structural schematic diagram of an immunoassay analyzer provided in one embodiment.

[0025] Figure 2 for Figure 1 The diagram shows a partial three-dimensional structure of the immunoassay analyzer chassis after some structures have been removed.

[0026] Figure 3 for Figure 1 The diagram shows a three-dimensional structural schematic of the cleaning and analysis device in the immunoassay analyzer.

[0027] Figure 4 for Figure 3 The diagram shows a three-dimensional structure of the cleaning and separation device from another perspective.

[0028] Figure 5 for Figure 3 The diagram shows a partial three-dimensional structure of the cleaning and separation device when used with the sample rack and reagent kit.

[0029] Figure 6 for Figure 3 The diagram shows a partial three-dimensional structure of the cleaning and separation device when it is not used with the sample rack and reagent kit.

[0030] Figure 7 for Figure 3 A three-dimensional structural diagram of the magnetic collection component in the cleaning and separation device shown.

[0031] Figure 8 This is a process flow diagram of a cleaning and separation method provided in one embodiment.

[0032] Reference numerals: 10 for cleaning and separation device, 11 for chassis, 20 for immunoassay analyzer, 30 for reactor, 41 for sample tube, 42 for reagent kit, 100 for magnetic collection mechanism, 110 for pipetting station, 120 for injection station, 121 for first injection station, 122 for second injection station, 130 for transfer station; 140 for magnetic collection assembly, 141 for carrier, 1411 for groove, 142 for magnetic component, 143 for collection position, 1431 for first collection position, 1432 for second collection position, 1433 for third collection position, 1434 for fourth collection position, 144 for sample addition position, 150 for belt drive assembly, 200 for injection mechanism, 210 for first injection assembly, 220 for second injection assembly, 300 for sampling mechanism, 310 for sampling component, 400 for transfer mechanism, 410 for gripper, 500 for mixing mechanism, 600 for incubation mechanism. Detailed Implementation

[0033] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0034] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0035] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0036] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0037] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0038] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0039] See Figure 1 , Figure 2 , Figure 3 and Figure 4 In one embodiment of this application, a cleaning and separation device 10 is provided that can be applied to an immunoassay analyzer 20. The cleaning and separation device 10 includes a magnetic collection mechanism 100, a liquid injection mechanism 200, a sampling mechanism 300, a transfer mechanism 400, a mixing mechanism 500, and an incubation mechanism 600.

[0040] See Figure 5 , Figure 6 and Figure 7In some embodiments, the magnetic collection mechanism 100 has a pipetting station 110 and an injection station 120, which are spaced apart. The magnetic collection mechanism 100 includes a magnetic collection component 140 and a belt drive component 150. The magnetic collection component 140 carries the reactor 30, and the belt drive component 150 drives the magnetic collection component 140 to move linearly via a synchronous belt, causing the magnetic collection component 140 to reciprocate linearly between the pipetting station 110 and the injection station 120. When the reactor 30 is at the pipetting station 110, the reaction liquid can be injected into the reactor 30.

[0041] See Figure 5 , Figure 6 and Figure 7 In some embodiments, the magnetic collection mechanism 100 also includes a transfer station 130. The pipetting station 110, the injection station 120, and the transfer station 130 are spaced apart along the direction of movement of the magnetic collection assembly 140, i.e., the pipetting station 110, the injection station 120, and the transfer station 130 are arranged in a straight line. The injection station 120 may be located between the pipetting station 110 and the transfer station 130. The reactor 30 can move into or out of the entire magnetic collection mechanism 100 at the transfer station 130. In other embodiments, the transfer station 130 may be omitted, for example, so that the pipetting station 110 and the injection station 120 have the function of the transfer station 130.

[0042] See Figure 5 , Figure 6 and Figure 7 In some embodiments, the injection mechanism 200 may include a first injection component 210 and a second injection component 220, and there are two injection stations 120, designated as the first injection station 121 and the second injection station 122. When the magnetic collection component 140 moves the reactor 30 to the first injection station 121, the first injection component 210 injects cleaning fluid into the reactor 30 located at the first injection station 121. When the magnetic collection component 140 moves the reactor 30 to the second injection station 122, the second injection component 220 injects substrate liquid into the reactor 30 located at the second injection station 122. In other embodiments, the first injection station 121 and the second injection station 122 may be the same station, and the first injection component 210 and the second injection component 220 may also be the same injection component.

[0043] See Figure 5 , Figure 6 and Figure 7In some embodiments, the magnetic collection assembly 140 includes a support member 141 and a magnetic member 142. The support member 141 supports the reactor 30, and the magnetic member 142 is fixedly mounted on the support member 141. The support member 141 has a collection position 143 and a sample addition position 144. Both the collection position 143 and the sample addition position 144 may have insertion holes, into which the reactor 30 can be inserted, thereby realizing the support function of the support member 141 in supporting the reactor 30. Alternatively, clamping bodies may be provided at the collection position 143 and the sample addition position 144, allowing the reactor 30 to be fixed, thus also realizing the support function of the support member 141 in supporting the reactor 30. The sample addition position 144 and the collection position 143 are spaced apart along the movement direction of the magnetic collection assembly 140, that is, the spacing direction of the sample addition position 144 and the collection position 143 is consistent with the movement direction of the support member 141.

[0044] See Figure 5 , Figure 6 and Figure 7 In some embodiments, the number of sample addition positions 144 is not less than two, and the number of collection positions 143 is greater than or equal to the number of sample addition positions 144. For example, the number of sample addition positions 144 can be two, and the number of collection positions 143 can be four, etc. By having multiple sample addition positions 144 and collection positions 143, the carrier 141 can simultaneously carry multiple reactors 30 for cleaning and separation operations, thereby improving the working efficiency of the cleaning and separation device 10.

[0045] See Figure 5 , Figure 6 and Figure 7 The support member 141 can have grooves 1411, and there can be multiple grooves 1411. Multiple grooves 1411 are arranged at intervals along the movement direction of the magnetic collection assembly 140. The grooves 1411 can be arranged between two adjacent collection positions 143. The magnetic element 142 can be fixed in the groove 1411. When there is a reactor 30 in two adjacent collection positions 143 on both sides of the groove 1411, the magnetic element 142 can generate a magnetic attraction force on the material in the reactor 30 in the two collection positions 143. In this way, the two collection positions 143 share a magnetic element 142, avoiding the need to set a magnetic element 142 for each collection position 143, thereby reducing the number of magnetic elements 142 used and thus reducing the manufacturing cost of the cleaning and separation device 10.

[0046] In some embodiments, a groove 1411 on the support member 141 is disposed on the side of the corresponding collection position 143, and a magnetic element 141 is fixed in the groove 1411. When a reactor 30 is present in the collection position 143 corresponding to the groove 1411, the magnetic element 142 generates a magnetic attraction force on the material in the reactor 30 in the corresponding collection position 143. The magnetic element 141 being disposed on the side of the corresponding collection position 143 can shorten the length of the magnetic collection assembly 140 along the direction of movement, reduce the space occupied by the entire magnetic collection assembly 140, and thus reduce the volume of the immunoassay analyzer 20. See also... Figure 1 , Figure 2 and Figure 3 In some embodiments, the sampling mechanism 300 may include a sampling element 310, which can move vertically up and down, horizontally left and right, and / or forward and backward in the horizontal direction. That is, the sampling element 310 may have two or three degrees of freedom in linear motion, or it can be understood as having two-dimensional or three-dimensional linear motion. The sampling element 310 can inject a reaction solution into the reactor 30. The reaction solution may include reagents and samples. Specifically, the sample may be placed in the sample tube 41 of the sample holder, and the reagent may be placed in the reagent kit 42. The sampling element 310 can draw samples from the sample tube 41 and inject them into the reactor 30, or it can draw reagents from the reagent kit 42 and inject them into the reactor 30 containing the sample, so that the reaction solution formed by the mixing of the sample and reagents can produce a chemical reaction.

[0047] In some embodiments, the cleaning and separation device 10 further includes a cleaning tank. Since reagents and samples are drawn up through the same sampling element 310, to avoid cross-contamination, after the sampling element 310 has finished drawing up the sample, it can be moved to the cleaning tank for cleaning. The cleaning tank cleans the sampling element 310, preventing sample adhering to the sampling element 310 from contaminating the reagent when it draws up the reagent. Similarly, after the sampling element 310 has finished drawing up the reagent, it can be moved to the cleaning tank for cleaning, preventing reagent adhering to the sampling element 310 from contaminating the sample when it draws up the sample.

[0048] See Figure 1 , Figure 2 and Figure 3In some embodiments, the transfer mechanism 400 includes a gripper 410 for holding the reactor 30 to transfer it, for example, the gripper 410 can move the reactor 30 off or into the magnetic collection assembly 140. The gripper 410 can move up and down in the vertical direction, and can also move left and right and / or back and forth in the horizontal direction, that is, the gripper 410 can have two or three degrees of freedom of linear motion, or it can be understood that the gripper 410 has two-dimensional or three-dimensional linear motion.

[0049] See Figure 1 , Figure 2 and Figure 3 In some embodiments, the mixing mechanism 500 can mix the liquid in the reactor 30. For example, the mixing mechanism 500 can cause the reactor 30 to oscillate through eccentric oscillation, thereby mixing the liquid in the reactor 30. The mixing mechanism 500 has at least two mixing positions, and insertion holes can be opened at the mixing positions. The reactor 30 can be inserted into the insertion holes, so that the mixing positions can support the reactor 30. Since there can be multiple mixing positions, the mixing mechanism 500 can mix the liquid in multiple reactors 30 simultaneously, thereby improving the working efficiency of the mixing mechanism 500 and the entire cleaning and separation device 10. The number of mixing mechanisms 500 can be one, which can reduce the number of mixing mechanisms 500 used, thereby simplifying the structure of the cleaning and separation device 10 and ultimately reducing the manufacturing cost and volume of the cleaning and separation device 10.

[0050] In some embodiments, the sampling mechanism 300 and the transfer mechanism 400 are located on opposite sides of the movement trajectory of the magnetic collection component 140 in a direction perpendicular to the movement direction of the magnetic collection component 140. This avoids collisions and interference between the gripper 410 and the sampling component 310 during movement, thereby improving the reliability and safety of the cleaning and analysis device 10. Furthermore, it allows for a more efficient layout of the sampling mechanism 300 and the transfer mechanism 400, improving the space utilization of the cleaning and separation device 10 and ultimately reducing its footprint and volume.

[0051] See Figure 1 , Figure 2 and Figure 3 In some embodiments, the incubation mechanism 600 has multiple insertion holes for placing the reactor 30, thus enabling the incubation mechanism 600 to support the reactor 30. The incubation mechanism 600 can heat the reactor 30 at a constant temperature, allowing the reaction liquid inside the reactor 30 to react sufficiently for a certain period of time under constant temperature conditions, thereby achieving the incubation function of the incubation mechanism 600 on the reactor 30.

[0052] See Figure 3 , Figure 5 , Figure 6 and Figure 7 The working principle of the cleaning and separation device 10 is described below. This working principle can be understood as a method for cleaning and separating the reactor 30. This working principle can be broken down into the following working steps:

[0053] The first step involves the gripper 410 performing a two-dimensional or three-dimensional linear motion. The gripper 410 clamps the empty reactor 30, causing the magnetic collection assembly 140 to move. This moves a sample loading position 144 on the magnetic collection assembly 140 to the transfer station 130. The gripper 410 then places the empty reactor 30 from the transfer station 130 into the sample loading position 144 of the magnetic collection assembly 140, and finally, the gripper 410 moves away from the transfer station 130.

[0054] In the second step, the magnetic collection component 140 drives the empty reactor 30 to the pipetting station 110, and the sampling component 310 moves and adds the sample and reagent to the reactor 30 at the pipetting station 110. At this time, the reactor 30 is filled with the reaction solution formed by the sample and reagent.

[0055] For example, sampling device 310 can first draw a sample from sample tube 41 and add the sample to reactor 30. Then, sampling device 310 can move to a cleaning tank to clean its inner and outer surfaces. After cleaning, sampling device 310 draws reagent from reagent kit 42 and adds the reagent to reactor 30. Alternatively, sampling device 310 can first draw a sample from sample tube 41, then move the sample-bearing sampling device 310 to a cleaning tank to clean its outer surface. Next, sampling device 310 draws reagent from reagent kit 42, then simultaneously adds the sample and reagent to reactor 30, and finally moves to a cleaning tank to clean its inner and outer surfaces. For example, the sampling device 310 can first draw reagents from the reagent kit 42 and add the reagents to the reactor 30, and then move the sampling device 310 to the cleaning tank to clean the inner and outer surfaces of the sampling device 310. After cleaning, the sampling device 310 draws samples from the sample tube 41 and adds the samples to the reactor 30.

[0056] In the third step, the magnetic collection component 140 moves the reactor 30 containing the reaction liquid to the transfer station 130. The gripper 410 moves to the transfer station 130 and removes the reactor 30 from the magnetic collection component 140. Then, the reactor 30 is moved into the mixing mechanism 500, where the mixing mechanism 500 mixes the reaction liquid in the reactor 30 to ensure a complete reaction. In fact, the reagent contains solid magnetic beads, so the reaction liquid is actually a suspension. When the sample and reagent react, the useful substance (the analyte) combines with the magnetic beads to form a complex. This complex can be used as a measurement target in subsequent testing and analysis, thus enabling the detection of different test items on the sample.

[0057] The fourth step involves moving the gripper 410 and removing the reactor 30, after mixing, from the mixing mechanism 500. Then, the reactor 30 is moved into the incubation mechanism 600, whereby the incubation mechanism 600 heats the reaction liquid in the reactor 30 at a constant temperature for a certain period of time, allowing the useful substances in the reaction liquid to fully combine with the magnetic beads to form a bound substance.

[0058] Fifth step, for ease of description, for example, when there are four collection positions 143, the four collection positions 143 are respectively referred to as the first collection position 1431, the second collection position 1432, the third collection position 1433, and the fourth collection position 1434. According to the movement direction of the magnetic collection component 140, the first collection position 1431, the second collection position 1432, the third collection position 1433, and the fourth collection position 1434 are arranged sequentially, with the fourth collection position 1434 being the closest to the sample addition position 144, and the first collection position 1431 being the furthest from the sample addition position 144. The gripper 410 moves and removes the reactor 30 after incubation from the incubation mechanism 600, causing the magnetic collection component 140 to move the first collection position 1431 to the transfer station 130, and then the gripper 410 places the reactor 30 from the transfer station 130 into the first collection position 1431.

[0059] In the sixth step, the magnetic collection component 140 moves the reactor 30 at the first collection position 1431 to the first liquid injection station 121. The first liquid injection component 210 injects cleaning liquid into the reactor 30 at the first liquid injection station 121, so that the cleaning liquid comes into contact with the binding material on the magnetic beads, thereby cleaning the binding material to a certain extent.

[0060] In the seventh step, the magnetic collection component 140 moves the first collection position 1431 to the transfer station 130, the gripper 410 moves and moves the reactor 30 out of the first collection position 1431 at the transfer station 130, then the magnetic collection component 140 moves the second collection position 1432 to the transfer station 130, and then the gripper 410 moves and moves the reactor 30 into the second collection position 1432 at the transfer station 130.

[0061] In the eighth step, due to the magnetic field generated by the magnetic component 142, the magnetic beads will migrate in the reaction liquid under the influence of the magnetic component 142 until they are adsorbed onto the inner wall surface of the reactor 30. This causes the binding material on the magnetic beads to also be adsorbed onto the inner wall surface of the reactor 30. Generally, it takes 10 to 90 seconds to adsorb all the magnetic beads onto the inner wall surface of the reactor 30.

[0062] In other embodiments, the cleaning solution may not be added to the reaction solution, thus the sixth step can be omitted, allowing direct access from the fifth step to the seventh step. Therefore, before removing the waste liquid from the reactor 30 containing the reaction solution, the reactor 30 can be moved to the liquid injection station 120 to inject the cleaning solution, or the cleaning solution may not be injected into the reactor 30.

[0063] In the ninth step, the magnetic collection component 140 moves the second collection position 1432 to the liquid transfer station 110, the sampling component 310 moves and completely absorbs the waste liquid in the reactor 30, and then the sampling component 310 moves to the cleaning tank and discharges the waste liquid into the cleaning tank. The cleaning tank will also clean the inner and outer surfaces of the sampling component 310 to prevent the waste liquid remaining in the sampling component 310 from causing cross-contamination.

[0064] In the tenth step, the magnetic collection component 140 moves the second collection position 1432 to the first liquid injection station 121, and the first liquid injection component 210 injects cleaning liquid into the reactor 30 located at the first liquid injection station 121.

[0065] In the eleventh step, the magnetic collection component 140 moves the second collection position 1432 to the transfer station 130. The gripper 410 moves and moves the reactor 30 from the transfer station 130 out of the magnetic collection component 140. Then, the reactor 30 is moved into the mixing mechanism 500. The mixing mechanism 500 mixes the suspension formed by the cleaning liquid and the magnetic beads. During the mixing process, the cleaning liquid cleans the aggregates attached to the magnetic beads.

[0066] In the twelfth step, the gripper 410 moves and moves the reactor 30, which has been mixed, out of the mixing mechanism 500, so that the magnetic collection component 140 drives the third collection position 1433 to the transfer station 130, and the gripper 410 puts the reactor 30 from the transfer station 130 into the third collection position 1433.

[0067] Step 13: Due to the magnetic field generated by the magnetic component 142, the magnetic beads will migrate in the reaction liquid under the influence of the magnetic component 142 until they are adsorbed onto the inner wall surface of the reactor 30. This causes the binding material on the magnetic beads to also be adsorbed onto the inner wall surface of the reactor 30. Generally, it takes 10 to 90 seconds to adsorb all the magnetic beads onto the inner wall surface of the reactor 30.

[0068] In the fourteenth step, the magnetic collection component 140 drives the third collection position 1433 to the liquid transfer station 110. The sampling component 310 moves and absorbs all the waste liquid in the reactor 30. Then the sampling component 310 moves to the cleaning tank and discharges the waste liquid into the cleaning tank. The cleaning tank will also clean the inner and outer surfaces of the sampling component 310 to prevent the waste liquid remaining in the sampling component 310 from causing cross-contamination.

[0069] At this point, steps 10 to 14 can be considered as a first-stage cleaning and separation process, that is, the process from the injection of cleaning liquid to the subsequent removal of waste liquid from reactor 30 after the reaction liquid has been completely absorbed is recorded as a first-stage cleaning and separation process. In the presence of step 6, steps 6 to 9 can be considered as a pre-cleaning and separation process. The entire cleaning and separation process of a reactor 30 can include multiple stages of cleaning and separation processes. For example, the entire cleaning and separation process may include two stages of cleaning and separation processes, and steps 10 to 14 above will become the first-stage cleaning and separation process. When the entire cleaning and separation process includes two stages of cleaning and separation processes, steps 10 to 14 can be cycled again. Specifically, the working principle of the cleaning and separation device 10 can be broken down into the following steps:

[0070] In the fifteenth step, the magnetic collection component 140 drives the third collection position 1433 to the first liquid injection station 121, and the first liquid injection component 210 injects cleaning liquid into the reactor 30 located at the first liquid injection station 121.

[0071] In the sixteenth step, the magnetic collection component 140 moves the third collection position 1433 to the transfer station 130. The gripper 410 moves and moves the reactor 30 from the transfer station 130 out of the magnetic collection component 140. Then the reactor 30 is moved into the mixing mechanism 500. The mixing mechanism 500 mixes the suspension formed by the cleaning liquid and the magnetic beads. During the mixing process, the cleaning liquid cleans the aggregates attached to the magnetic beads.

[0072] In the seventeenth step, the gripper 410 moves and moves the reactor 30, which has been mixed, out of the mixing mechanism 500, so that the magnetic collection component 140 drives the fourth collection position 1434 to the transfer station 130, and the gripper 410 puts the reactor 30 from the transfer station 130 into the fourth collection position 1434.

[0073] Step 18: Due to the magnetic field generated by the magnetic component 142, the magnetic beads will migrate in the reaction liquid under the influence of the magnetic component 142 until they are adsorbed onto the inner wall surface of the reactor 30. This causes the binding material on the magnetic beads to also be adsorbed onto the inner wall surface of the reactor 30. Generally, it takes 10 to 90 seconds to adsorb all the magnetic beads onto the inner wall surface of the reactor 30.

[0074] In the nineteenth step, the magnetic collection component 140 drives the fourth collection position 1434 to the liquid transfer station 110. The sampling component 310 moves and absorbs all the waste liquid in the reactor 30. Then, the sampling component 310 moves to the cleaning tank and discharges the waste liquid into the cleaning tank. The cleaning tank will also clean the inner and outer surfaces of the sampling component 310 to prevent the waste liquid remaining in the sampling component 310 from causing cross-contamination.

[0075] After step nineteen is completed, that is, after reactor 30 finishes its final waste liquid extraction, the entire effective cleaning and separation process of the magnetic beads and the conjugate is essentially complete. At this point, steps fifteen through nineteen become the second-stage cleaning and separation treatment. To diversify the functions of the cleaning and separation device 10, reactor 30 can be moved to the second liquid injection station 122 to inject substrate liquid into reactor 30, mixing the substrate liquid, magnetic beads, and conjugate for subsequent measurement and analysis. Based on this, the working principle of the cleaning and separation device 10 can be further broken down into the following steps:

[0076] In the twentieth step, the magnetic collection component 140 drives the fourth collection position 1434 to the second liquid injection station 122, and the second liquid injection component 220 injects the substrate liquid into the reactor 30 located at the second liquid injection station 122.

[0077] In the twenty-first step, the magnetic collection component 140 drives the fourth collection position 1434 to the transfer station 130. The gripper 410 moves and moves the reactor 30 from the transfer station 130 out of the magnetic collection component 140. Then the reactor 30 is moved into the mixing mechanism 500, which mixes the suspension formed by the substrate liquid, magnetic beads and conjugate.

[0078] In the twenty-second step, the gripper 410 moves and removes the reactor 30, after mixing, from the mixing mechanism 500, and then moves the reactor 30 into the incubation mechanism 600 so that the incubation mechanism 600 can heat the liquid in the reactor 30 at a constant temperature for a certain period of time.

[0079] Step 23: The gripper 410 moves and removes the reactor 30, which has completed incubation, from the incubation mechanism 600, and moves the reactor 30 into the measuring mechanism for subsequent measurement and analysis.

[0080] If different aspiration needles are used for sample injection, reagent injection, and waste liquid aspiration, this will increase the number of aspiration needles used and the number of driving sources required to move them, thus increasing the manufacturing cost and size of the cleaning and separation device 10. Furthermore, given the movement of multiple aspiration needles, controlling their movement will be more difficult to minimize interference.

[0081] Regarding the cleaning and separation device 10 in the above embodiments, since the same sampling element 310 is used for sample injection, reagent injection, and waste liquid aspiration, the number of sampling elements 310 and the number of driving sources for moving the sampling elements 310 are reduced, thereby reducing the manufacturing cost and size of the cleaning and separation device 10. It also reduces the difficulty of motion control for a single sampling element 310.

[0082] If the magnetic collection component 140 adopts a rotary disc design, the disc rotates to move the reactor 30 to different positions to complete the cleaning and separation. This would increase the size of the disc, as well as the number of suction needles and their associated drive sources, thus increasing the manufacturing cost and size of the cleaning and separation device 10. Furthermore, the increased weight and size of the disc make motion control more difficult, potentially affecting its motion accuracy and increasing the failure rate.

[0083] Regarding the cleaning and separation device 10 in the above embodiments, since the magnetic collection component 140 moves linearly between the transfer station 130, the liquid injection station 120, and the liquid transfer station 110, the control difficulty of linear movement is significantly reduced. This improves the accuracy of the movement of the magnetic collection component 140 and reduces the failure rate, while also reducing the volume of the magnetic collection component 140, thereby achieving a miniaturized design of the cleaning and separation device 10. Simultaneously, the arrangement direction of the sample addition position 144 and the collection position 143 on the magnetic collection component 140 is the same as the movement direction of the magnetic collection component 140, effectively avoiding the situation where the arrangement direction of the sample addition position 144 and the collection position 143 on the magnetic collection component 140 is perpendicular to the movement direction of the magnetic collection component 140. This makes the magnetic collection component 140 elongated, reducing the volume of the magnetic collection component 140 and the entire cleaning and separation device 10, and also reducing the space covered by the magnetic collection component 140 during movement, further reducing the volume of the cleaning and separation device 10 and achieving a miniaturized design of the cleaning and separation device 10.

[0084] If different mixing mechanisms 500 are used for mixing the reaction solution formed by the reagent and the sample, the washing solution and the magnetic beads, and the substrate solution and the magnetic beads, the number of mixing mechanisms 500 used will increase, thereby increasing the manufacturing cost and volume of the cleaning and separation device 10.

[0085] As for the cleaning and separation device 10 in the above embodiments, since the same mixing mechanism 500 is used for mixing the reaction liquid, the cleaning liquid and the magnetic beads, and the substrate liquid and the magnetic beads, the number of mixing mechanisms 500 used will be greatly reduced, thereby reducing the manufacturing cost of the cleaning and separation device 10 and realizing the miniaturization design of the cleaning and separation device 10.

[0086] Because the cleaning and separation device 10 has low manufacturing cost, small size and low motion control difficulty, the failure rate of the cleaning and separation device 10 can be reduced and the professional requirements for operation of the cleaning and separation device 10 can be reduced, thus enabling the cleaning and separation device 10 to be widely used in small and medium-sized laboratories or medical institutions.

[0087] Since there are multiple collection points 143, for two adjacent collection points 143, the reactor 30 is injected with cleaning liquid at one collection point 143 and then transferred to the other collection point 143 to collect waste liquid. This allows the magnetic collection assembly 140 to simultaneously support multiple reactors 30 for cleaning and separation. That is, reactors 30 that have completed cleaning and separation can be sequentially removed from the magnetic collection assembly 140, while reactors 30 requiring cleaning and separation can be sequentially moved into the magnetic collection assembly 140. This improves the working efficiency of the cleaning and separation device 10 to a certain extent.

[0088] See Figure 1 and Figure 2 In some embodiments, the cleaning and separation device 10 may further include a housing 11. The magnetic collection mechanism 100, the sampling mechanism 300, the mixing mechanism 500, the liquid injection mechanism 200, the transfer mechanism 400, and the incubation mechanism 600 may all be housed within the housing 11.

[0089] See Figure 8 By operating the aforementioned cleaning and separation device 10, the following cleaning and separation method can be formed. This method can be understood as being executed by the cleaning and separation device 10. Based on the linear movement of the reactor 30 carried by the magnetic collection component 140 between the spaced-apart transfer station 110 and injection station 120, the cleaning and separation method mainly consists of the following steps:

[0090] S710, Move the empty reactor 30 to the pipetting station 110 and inject the reaction liquid into the reactor 30 through the sampling mechanism 300.

[0091] S720, Remove the reactor 30 after the reaction liquid has been injected from the magnetic collection assembly 140.

[0092] S730. Mix the liquid in reactor 30.

[0093] S740. The well-mixed reactor 30 is transferred to the incubation unit 600 for incubation.

[0094] S750, after incubation, the reactor 30 is moved into the magnetic collection assembly 140 and then to the liquid transfer station 110. The magnetic beads in the reactor 30 are collected on the inner wall of the reactor 30, and the waste liquid is extracted by the sampling mechanism 300.

[0095] S760, after the waste liquid is absorbed, the reactor 30 is moved to the liquid injection station 120, and the cleaning liquid is injected into the reactor 30 through the first liquid injection component 210.

[0096] S770, Remove the reactor 30 after the cleaning fluid has been injected from the magnetic collection assembly 140;

[0097] S780, and mix the liquid in reactor 30.

[0098] S790, The reactor 30 containing the cleaning solution is moved to the transfer station 110 to collect the magnetic beads in the reactor 30 on the inner wall of the reactor 30, and the waste liquid is extracted by the sampling mechanism 300.

[0099] For the other steps of the cleaning method, please refer to the above description of the structure and working principle of the cleaning and separation device 10, which will not be repeated here.

[0100] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0101] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A cleaning and separation method, characterized in that, The cleaning and separation method involves a reactor, carried by a magnetic collection assembly, moving linearly between spaced-apart pipetting and injection stations. The method comprises the following steps: The empty reactor is moved to the liquid transfer station, and the reaction liquid is injected into the reactor through the sampling mechanism; Remove the reactor after the reaction solution has been injected from the magnetic collection assembly; Mix the liquid in the reactor thoroughly; The well-mixed reactor is then transferred to an incubation apparatus for incubation. After incubation, the reactor is moved into the magnetic collection assembly and then to the liquid transfer station. The magnetic beads in the reactor are collected on the inner wall of the reactor, and the waste liquid is extracted through the sampling mechanism. After the waste liquid is absorbed, the reactor is moved to the liquid injection station, and cleaning liquid is injected into the reactor through the first liquid injection component; Remove the reactor from the magnetic collection assembly after the cleaning fluid has been injected; The liquid in the reactor is mixed; the reactor containing the cleaning solution is moved to the transfer station to collect the magnetic beads in the reactor on the inner wall of the reactor, and the waste liquid is removed through the sampling mechanism; The magnetic collection assembly has a sample addition position and a collection position for carrying the reactor. The sample addition position and the collection position are spaced apart along the movement direction of the magnetic collection assembly. The sample addition position can move to the pipetting station, and the collection position can move to the pipetting station or the injection station. The number of collection locations is multiple. For two adjacent collection locations, the reactor injects cleaning liquid into one collection location and then moves to the other collection location to collect waste liquid.

2. The cleaning and separation method according to claim 1, characterized in that, The magnetic collection assembly carries the reactor through a transfer station that is spaced apart from the pipetting station and the injection station. The magnetic collection assembly moves linearly between the pipetting station, the injection station, and the transfer station, and moves the reactor into or out of the magnetic collection assembly at the transfer station.

3. The cleaning and separation method according to claim 2, characterized in that, The injection station is positioned between the pipetting station and the transfer station.

4. The cleaning and separation method according to claim 1, characterized in that, After the reactor has finished its last waste liquid extraction, the substrate liquid is injected into the reactor at the injection station via the second injection assembly.

5. The cleaning and separation method according to claim 4, characterized in that, The number of injection stations is two, and the two injection stations are respectively designated as the first injection station and the second injection station. Cleaning liquid is injected into the reactor at the first injection station, and substrate liquid is injected into the reactor at the second injection station.

6. The cleaning and separation method according to claim 1, characterized in that, The number of sample application sites shall not be less than two.

7. The cleaning and separation method according to claim 1, characterized in that, The number of collection locations is greater than or equal to the number of sample application locations.

8. The cleaning and separation method according to claim 1, characterized in that, Before the reactor containing the reaction liquid is drained of waste liquid, the reactor is moved to the liquid injection station to inject cleaning liquid.

9. The cleaning and separation method according to claim 1, characterized in that, The step from the injection of cleaning liquid into the reactor after the reaction liquid has been completely absorbed until the waste liquid is absorbed again is referred to as the first-stage cleaning and separation process. The cleaning and separation method includes multiple stages of the cleaning and separation process.

10. The cleaning and separation method according to claim 1, characterized in that, It also includes at least one of the following steps: The liquid in the reactor is mixed using the same mixing mechanism; After the sampling mechanism injects the reaction liquid or removes the waste liquid, the sampling component of the sampling mechanism is cleaned.

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